Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Introductory Module 1

FREE to Attend | Live & Recorded

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TBD | 60 mins | 1:00 PM UK

The role of regulatory affairs

• An Overview of Regulatory Affairs and European / US Legislation
• Understanding where we interact during the development cycle
• Provision of strategy and guidance (how to use guidance)
• Project and product management – the interface
• Role within the organisation

Session 1

TBD

Drug discovery to first administration in man: The influential role of regulatory affairs
This session will provide insight, with practical examples, on the issues surrounding new drug development, principally as seen from a regulatory perspective.

Clinical Phase I to Phase III – advancing towards the MAA CTD
While developing drugs there are issues, tasks, regulations & procedures that have to be considered. This session will be an opportunity to work through the following challenges:

• Clinical Development Phase I to III : requirements and applications across the EU
• Reconciling manufacturing, non-clinical and clinical demands within the regulatory framework and commercial imperatives
• Guidelines on specific therapeutic areas
  

Session 2

TBD

Problems to be dealt with by the Regulatory Project Leader as the ‘product’ progresses through the later stages of development

• Identify study and data requirements in order to progress your product through the clinic and towards the market
• Advise on the clinical development programme
• Resolve manufacturing, non-clinical and clinical problems as you strive to achieve the earliest filing date for your products MAA / CTD
• Identify the need for, and timing of, Scientific Advice
• Modify the Target Drug Profile (TDP) as more data becomes available

A review of key areas

• Orphan Applications
• ATMP legislation
• Generic Criteria
• Paediatric Legislation
• Accelerated development processes in EU and US

Session 3

TBD

Filing and negotiating approval of the Marketing Authorisation Application (MAA) or Common Technical Document (CTD)
The aim of this session is to identify the main hurdles that regulatory affairs executives face during the MAA / CTD submission. It will take the form of a top-level discussion where best practices will be highlighted by the trainers. Delegates will also be encouraged to put forward their questions and experiences

• Review of key legislation including the recent Directives and regulations
• Scientific advice from EMA and national agencies
• What are the requirements for a successful and readily approvable MAA/CTD?
• Selecting the registration procedure: MRP, DCP or Centralised Procedure

Working through a MAA / CTD for your product, negotiating with the relevant authorities

• Prepare the SPC
• Resolve the objections / consolidated list of questions with the authorities
• Negotiate final approval

Session 4

TBD

Regulatory affairs beyond the MAA

This session will demonstrate strategic approaches to help you manage your regulatory projects from initiation to completion, and assist in your objective to succeed within
your organisation.

• Regulatory Intelligence and competitive advantage
• Design a post-approval strategy to give marketing colleagues the ability to claim advantages over competitor products,
• Optimising your product potential
• How to be positive and a solution-seeker for your organisation and not a regulatory obstacle
• Effective utilisation of contract service organisations
• Regulatory negotiations at senior management level

The lifecycle of products

• A review of lifecycle management – The Vauban Strategy
• Maintenance – Change Control Explained – interpreting the definitions
• Overcome the regulatory hurdles as changes are made to the manufacturing process and the safety profile of the ‘product’
• Global Role out of dossiers

Andrew Willis is a regulatory and development consultant with 35 years of experience. His management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.

He currently delivers extensive training courses in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.